LORAZEPAM UALAN 0.25 MG Coated tablet

Содержание инструкции

1. Lorazepam Hualan 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets, 2.5 mg tablets
   1. What is Lorazepam Hualan and what is it used for
   2. What you need to know before taking Lorazepam Hualan
   3. How to take Lorazepam Hualan tablets
   4. Possible side effects
   5. How to store Lorazepam Hualan
   6. Contents of the pack and other information

Lorazepam Hualan 0.25 mg tablets, 0.5 mg tablets, 1 mg tablets, 2.5 mg tablets

lorazepam

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Lorazepam Hualan is and what it is used for
• 2. What you need to know before you take Lorazepam Hualan
• 3. How to take Lorazepam Hualan
• 4. Possible side effects
• 5. How to store Lorazepam Hualan
• 6. Contents of the pack and other information

1. What is Lorazepam Hualan and what is it used for

Lorazepam Hualan is a sedative and anxiolytic (tranquilizer) drug belonging to the group of
active substances called benzodiazepines.
Lorazepam Hualan is used in adults for the short-term treatment of anxiety or sleep disorders
due to anxiety.
It can also be used as a sedative before diagnostic procedures and surgical interventions in
adults, adolescents and children starting from 6 years of age.
Lorazepam Hualan should not be used for the treatment of mild or moderate anxiety in
adults or for anxiety and sleep disorders in children.

2. What you need to know before taking Lorazepam Hualan

Do not take Lorazepam Hualan
─ if you are allergic to lorazepam, to other benzodiazepines or to any of the other ingredients of
this medicine (listed in section 6).
─ if you have severe liver problems (severe hepatic insufficiency)
─ if you are pregnant (see section "Pregnancy and breastfeeding")
─ if you have, or have had in the past, a dependence on drugs, alcohol or narcotics
─ if you experience abnormal muscle weakness (myasthenia gravis)
─ if you have disorders of motor coordination (spinal and cerebellar ataxias)
─ in case of acute intoxication with alcohol or drugs that depress the central nervous system (e.g.
sleeping pills or painkillers, drugs for the treatment of mental disorders such as neuroleptics,
antidepressants and lithium)
─ if you suffer from breathing problems during sleep (sleep apnea syndrome)
─ if you suffer from severe respiratory problems (chronic obstructive bronchopneumopathy)
Lorazepam Hualan should not be used in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam Hualan if:
─ you suffer from depression, as Lorazepam Hualan may increase thoughts or impulses to harm yourself
─ you are an elderly person, you may be more likely to fall
─ you have liver problems
─ you abuse or have abused medicines or alcohol
─ you have chronic breathing difficulties
─ you have been diagnosed with angioedema (sudden swelling of the skin, mucous membranes or
internal organs) associated with treatment with benzodiazepines
In depressed patients, the appearance or worsening of depressive symptoms associated with the
disease is possible. In these patients, treatment with benzodiazepines may increase the risk of suicide;
lorazepam should not be administered without adequate antidepressant therapy. If you are depressed,
have irrational fears and obsessions, have begun to think about suicide or harm yourself, inform
your doctor immediately.
At the beginning of treatment, the doctor will monitor your individual response to this medicine to
detect any overdoses as early as possible. If you are a child, an elderly or debilitated patient, you may
show a more sensitive response to the effects of Lorazepam Hualan. Therefore, your therapy should be
monitored more frequently.
If you suffer from kidney or liver dysfunction, pre-existing heart failure and/or low blood
pressure (hypotension), you may be more sensitive to the effects of this medicine; the same applies
if you are elderly. You may be at greater risk of falls, especially when getting up during the
night.
The use of lorazepam can cause hepatic encephalopathy (a brain disease caused by liver damage).
Therefore, lorazepam should not be used in patients with severe liver problems and/or
with hepatic encephalopathy.
When used to promote sleep, you should make sure you get enough sleep (about 7-8 hours).
By following this recommendation, you can avoid any side effects (e.g.,
fatigue, reduced reaction times) the next morning. For detailed instructions
on how to manage your daily life, considering your specific situation (e.g., work activity), consult
your doctor.
Following the use of benzodiazepines, the appearance of "paradoxical" reactions has been
occasionally reported (see section 4). This type of reaction is to be expected in particular in children
and the elderly. If paradoxical reactions occur, treatment with
lorazepam should be discontinued.

Elderly patients
In elderly patients, lorazepam should be used with caution due to the risks of sedation and/or
muscle weakness, which may lead to an increased risk of falls, with serious
consequences for patients in this group. The dose should be reduced in elderly patients.
The use of benzodiazepines, including lorazepam, can cause breathing difficulties (respiratory
depression), which can be fatal.

Dependence
Lorazepam can cause dependence (potential primary dependence). Even if Lorazepam Hualan is
taken daily for a few weeks, it can lead to the development of physical and
psychological dependence. This risk does not only concern the abusive use of particularly high doses, but also
the therapeutic dosage range. The risk increases with the duration of treatment and with the dose and is
higher in patients with a history of alcohol or drug abuse or with marked personality disorders.
In general, benzodiazepines should only be prescribed for short periods (2-4 weeks). Continuous
use is only possible if strictly necessary, after a careful assessment of the benefit of
treatment versus the risk of dependence. Long-term use of Lorazepam Hualan is not
recommended. Therefore, you should take Lorazepam Hualan for the shortest possible time (see
section 4).
Treatment with Lorazepam Hualan should be discontinued gradually to avoid withdrawal symptoms.
See section 3 "If you stop taking Lorazepam Hualan".
Severe allergic reactions have been reported with the use of benzodiazepines. Cases of
angioedema (swelling of the skin and/or mucous membranes) involving the tongue, larynx or the
area of the larynx responsible for voice formation (glottis) have been reported after the ingestion of the first dose or subsequent doses of benzodiazepines. Some patients treated with benzodiazepines have manifested
other symptoms, such as shortness of breath (dyspnea), swelling of the throat or nausea and vomiting. First aid treatment was necessary for some patients. If angioedema affecting the tongue,
larynx or glottis occurs, the airways may become obstructed, with potentially fatal consequences.

Children and adolescents
Children and adolescents under the age of 18 should not be treated with Lorazepam Hualan unless
for urgent needs for sedation before diagnostic and surgical procedures.
Lorazepam Hualan should not be used in children under 6 years of age.

Other medicines and Lorazepam Hualan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The simultaneous use of Lorazepam Hualan with other medicines that depress the central nervous
system can lead to a mutual potentiation of the depressive effects of the central nervous
system, for example:

• medicines for the treatment of mental disorders (psychotropic drugs).
• sleeping pills, sedatives, anesthetics
• medicines for the treatment of high blood pressure (beta-blockers)
• some painkillers, medicines for substitution therapy and cough suppressants (opioids)
• medicines for allergies (antihistamines)
• medicines used for the treatment of convulsive disorders (antiepileptics)

The simultaneous use of Lorazepam Hualan and opioids (potent painkillers, medicines for substitution
therapy and some cough suppressants) increases the risk of drowsiness, breathing difficulties
(respiratory depression), coma and can be potentially fatal. For this reason, concomitant use should be considered only in the absence of other therapeutic options.
However, if Lorazepam Hualan is prescribed together with opioids, the doctor should
limit the dose and duration of concomitant treatment.
Tell your doctor about all opioid-based medicines you are taking and strictly follow
his recommendations regarding dosage. It may be helpful to ask friends or family to
pay attention to the signs and symptoms mentioned above that you may experience. Inform your doctor if
these symptoms occur.
The effect of medicines that reduce muscle tension (muscle relaxants) and analgesics may
be potentiated.
The concomitant use of lorazepam and clozapine can cause severe drowsiness, excessive salivation and
problems with motor coordination.
The concomitant administration of Lorazepam Hualan and valproic acid can cause an increase
in the concentrations of lorazepam in the blood. If valproic acid is used in conjunction
with Lorazepam Hualan, the dose of the latter should be reduced by about half.
The concomitant administration of Lorazepam Hualan and probenecid can accelerate the onset
or prolong the effect of lorazepam. The dosage of Lorazepam Hualan should be halved when
used in conjunction with probenecid.
The use of theophylline or aminophylline can reduce the sedative effects of Lorazepam Hualan.

Lorazepam Hualan with alcohol
Avoid consuming alcoholic beverages at the same time, as alcohol can alter and potentiate the
effects of Lorazepam Hualan in unpredictable ways.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Lorazepam Hualan should not be taken during pregnancy.
If pregnancy occurs during treatment with Lorazepam Hualan, inform your doctor immediately
so that he can decide whether to discontinue treatment. Prolonged use of
Lorazepam Hualan by a pregnant woman can cause withdrawal symptoms in the newborn.
If Lorazepam Hualan is administered towards the end of pregnancy or during childbirth, the
newborn may experience reduced activity, decreased muscle tone, lowering of the
body temperature (hypothermia) and/or blood pressure (hypotension), respiratory depression, apnea and weakness in sucking (the so-called "floppy infant syndrome").
Breastfeeding
Because the active ingredient of Lorazepam Hualan passes into breast milk, it should not be taken
during breastfeeding unless the expected benefit to the woman outweighs the potential risk to
the newborn. When Lorazepam Hualan is taken during breastfeeding, the newborn may
experience sedation and weakness in sucking. Careful clinical monitoring of
the newborn is recommended.

Driving and using machines
Even if you use Lorazepam Hualan as directed, you should expect some limitations in your ability
to react, especially during the first few days of treatment. You may therefore not be
able to react quickly enough to unexpected and sudden events. Do not drive a car or other
vehicles! Do not use dangerous machinery or power tools! Do not work without a secure foothold!
Pay particular attention to the fact that alcohol further worsens your ability to
react.
Your doctor will assess whether and to what extent it is safe for you to drive or perform other
risky activities, taking into account your individual ability to react and the dosage.

Lorazepam Hualan contains lactose
This medicine contains lactose. If you have been diagnosed with an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Lorazepam Hualan tablets

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage
The dose and duration of use must be adjusted to the individual response to treatment,
the scope of application and the severity of the illness. The guiding principle in this case is to maintain the
lowest possible dose and the shortest possible duration of treatment.
Treatment of anxiety and related sleep disorders.
The daily dose for adults is generally between 0.5 and 2.5 mg of lorazepam divided into
2 or 3 single doses or in a single evening dose. In individual cases, particularly in hospital, the doctor may
increase the daily dose up to a maximum of 7.5 mg of lorazepam, taking all
precautions into account. For dosages in a lower or higher range, preparations with lower or higher single doses are available.
If sleep disorders are the main concern, the daily dose (0.5 to 2.5 mg of
lorazepam) can be taken as a single dose about half an hour before bedtime; for this purpose
preparations with lower or higher single doses are also available.
Sedation before diagnostic and surgical procedures
In adults, 1 to 2.5 mg of lorazepam the evening before and/or 2 to 4 mg of lorazepam approximately 1-
2 hours before the surgical intervention. Preparations with lower or higher single doses are also available
suitable for lower or higher dosages.

Use in children and adolescents
Children from six years of age and adolescents
In children, the dose must be reduced accordingly; single doses must not exceed 0.5-1 mg
of lorazepam or 0.05 mg per kg of body weight. Preparations with lower single doses are available
suitable for lower dosages.

Use in elderly or debilitated patients
In elderly or debilitated patients and in patients with organic brain alterations, the total initial daily dose must be reduced by about 50%. The dose must be adjusted by the doctor based on
the desired effect and tolerability in individual cases.

Use in patients with impaired liver function
Do not take Lorazepam Hualan if you have severe liver problems (severe hepatic insufficiency).
Like all medicines that depress the central nervous system, benzodiazepines can cause encephalopathy (brain disease due to liver damage) in patients with severe liver failure.

Method of administration
Take the tablets without chewing, with some liquid (e.g. half a glass to a
glass of water). The score line is not intended for breaking the tablet. The tablets
can be taken independently of meals.
If used as a sleeping aid, the tablets should be taken about half an hour before bedtime and not
on a full stomach, otherwise a delay in the onset of effect and, depending on the duration of sleep, more intense residual effects in the morning may occur.

Duration of use
The duration of treatment will be determined by your doctor. In acute illnesses, the use of
Lorazepam Hualan should be limited to single doses or a few days. For chronic diseases, the
duration of treatment depends on the course of the disease. After 2 weeks of daily use, the
doctor should evaluate, by gradually reducing the dose, whether treatment with
Lorazepam Hualan is still indicated.
It should be noted that, following prolonged use (more than 1 week) and abrupt discontinuation of the
medicine, sleep problems, states of anxiety and tension, inner restlessness and agitation may reappear temporarily, but with greater intensity. Therefore, treatment should not be
stopped abruptly, but by gradually reducing the dosage.

If you take more Lorazepam Hualan than you should
If there is suspicion of intoxication after taking excessive doses of the medicine, it is necessary to
immediately inform a doctor. Follow the first aid instructions provided
by telephone. Do not induce vomiting without explicit instructions!
The signs indicating an overdose are: drowsiness, confusion, lethargy, reduced breathing,
problems with movements (coordination of movements), apathy and, in severe cases, loss of
consciousness.

If you forget to take Lorazepam Hualan
If you forget to take a tablet once, take Lorazepam Hualan as usual at the
next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Lorazepam Hualan
You should never stop or discontinue treatment on your own initiative, unless you suspect
a serious side effect. In this case, contact your treating doctor immediately.
If you suddenly stop treatment after following it for a long period, withdrawal symptoms indicated in paragraph 4 may occur. To avoid these phenomena, discontinue the
treatment by gradually reducing the dose (see paragraph 3).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are expected to occur particularly at the beginning of treatment, at very high doses and in
patient groups indicated in "Warnings and precautions" (see paragraph 2).

Very common: may affect more than 1 in 10 people

• sedation, fatigue, drowsiness

Common: may affect up to 1 in 10 people

• unstable movements and gait (ataxia)
• confusion
• depression, onset of depression
• dizziness
• muscle weakness, fainting

Uncommon: may affect up to 1 in 100 people

• changes in libido, impotence, less intense orgasm
• feeling unwell (nausea)

Not known: frequency cannot be estimated based on available data

• changes in blood cell count (thrombocytopenia, agranulocytosis, pancytopenia)
• prolonged reaction times
• difficulty in coordinating movements (extrapyramidal symptoms)
• tremor
• visual disturbances (double vision, blurred vision)
• difficulty articulating words/confused speech
• headache
• convulsions/seizures
• memory lapses (amnesia)
• disinhibition, euphoria
• coma
• thoughts/attempts of suicide
• problems with attention/concentration
• balance disorders
• vertigo
• paradoxical reactions such as anxiety, states of agitation, delirium, excitability, aggressive behavior (hostility, aggression, anger), sleep disorders/insomnia, sexual excitement, fixations. If such reactions occur, treatment with Lorazepam Hualan must be discontinued.
• low blood pressure (hypotension), mild drop in blood pressure
• respiratory depression (severity varies depending on the dose), shortness of breath (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep)
• worsening of obstructive bronchopneumopathy (constriction of the airways)
• constipation
• increased bilirubin
• jaundice, increased liver enzymes (transaminases, alkaline phosphatase)
• allergic skin reactions
• hair loss
• hypersensitivity reactions, anaphylactic/anaphylactoid reactions, swelling of the skin and/or mucous membranes (angioedema)
• inappropriate secretion of antidiuretic hormone (SIADH)
• low sodium levels in the blood (hyponatremia)
• decrease in body temperature (hypothermia)

Benzodiazepines cause dose-dependent depression of the central nervous system.

Dependence/Abuse
After a period of treatment, even for a few days, with daily intake of Lorazepam
Hualan, withdrawal symptoms (e.g. sleep disturbances, increased dreams) may occur upon discontinuation of therapy, especially if such discontinuation occurs abruptly. Anxiety, states of
tension, agitation and inner restlessness may reappear with greater intensity. Other
symptoms reported following discontinuation of benzodiazepines include: headache, depression,
confusion, irritability, sweating, depressed mood (dysphoria), dizziness, loss of sense of
reality, behavioral disturbances, exaggerated perception of sounds, numbness and tingling of the limbs,
hypersensitivity to light, noises and touch, altered perception, involuntary movements, nausea,
vomiting, diarrhea, loss of appetite, hallucinations/delirium, seizures/convulsions, tremors,
abdominal cramps, muscle pain, agitation, palpitations, accelerated pulse, panic attacks,
dizziness, exaggerated reflexes, short-term memory loss and fever. In case of chronic use of Lorazepam Hualan in epileptic patients or when taking other medicines that can
lower the seizure threshold (e.g., antidepressants), abrupt discontinuation of treatment can
trigger further seizures. The risk of withdrawal symptoms increases with the duration of treatment and the dose
previously taken. These phenomena can generally be avoided by gradually reducing the
dose.
The development of tolerance (increased dose due to habituation) to the sedative effect of benzodiazepines has been demonstrated.
Lorazepam has a potential for abuse. Patients with a history of drug and/or alcohol abuse are
particularly at risk.

What measures should be taken in case of side effects?
Many of the side effects listed above may disappear spontaneously during
treatment or by reducing the dose. If side effects persist, inform your doctor, who will need to
decide whether to discontinue treatment. Immediately inform your doctor if you develop unexplained
skin rashes, discoloration of the skin or swelling.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . Reporting side effects can help provide more information on
the safety of this medicine.

5. How to store Lorazepam Hualan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blisters after
“EXP”. The expiry date refers to the last day of that month.
Store the medicine at a temperature below 25 °C.
Keep the medicine in the original blister pack to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lorazepam Hualan contains

• The active ingredient is lorazepam. Each tablet contains 0.25 mg, 0.5 mg, 1 mg or 2.5 mg of lorazepam.
• The other ingredients are lactose monohydrate (see section 2 “Lorazepam Hualan contains lactose”), microcrystalline cellulose (E460), potassium polacrilin salt and magnesium stearate (E470b).

Description of the appearance of Lorazepam Hualan and contents of the pack

• The 0.25 mg tablets of Lorazepam Hualan are white, round, flat, with a beveled edge, with a score line on one side and smooth on the other side. The score line is not intended for breaking the tablet. The size of the tablet is 5.00 mm x 1.85 mm.
• The 0.5 mg tablets of Lorazepam Hualan are white, round, flat, with a beveled edge, with the letter “L” imprinted on one side and smooth on the other side. The size of the tablet is 6.00 mm x 2.60 mm.
• The 1 mg tablets of Lorazepam Hualan are white, round, flat, with a beveled edge, with the letter “M” imprinted on one side and smooth on the other side. The size of the tablet is 6.00 mm x 2.60 mm.
• The 2.5 mg tablets of Lorazepam Hualan are white, round, flat, with a beveled edge, with a score line on one side and smooth on the other side. The score line is not intended for breaking the tablet. The size of the tablet is 8.50 mm x 3.60 mm.

Lorazepam Hualan is available in OPA/Alu/PVC-Alu blisters of 28 tablets.

Marketing Authorisation Holder
Hualan Pharmaceuticals Limited
16/17 College Green, Dublin 2,
Dublin,
D02 V078
Ireland

Manufacturer
Elara Pharmaservices Europe Limited
239 Blanchardstown Corporate Park
Ballycoolin, Dublin, D15 KV21
Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Lithuania: Lorazepam Hualan 0.25 mg tabletės, Lorazepam Hualan 0.5 mg tabletės, Lorazepam Hualan
1 mg tabletės and Lorazepam Hualan 2.5 mg tabletės
Malta: Lorazepam Hualan 0.25 mg Tablets, Lorazepam Hualan 0.5 mg Tablets, Lorazepam Hualan
1 mg Tablets and Lorazepam Hualan 2.5 mg Tablets
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Attention to the patient!
This medicine contains an active ingredient belonging to the benzodiazepine group.
Benzodiazepines are medicines used to treat conditions associated with restlessness, anxiety,
internal tension or insomnia. Benzodiazepines are also used to treat epilepsy and
some muscle spasms.
Not all anxiety or sleep disorders require pharmacological treatment. Often, they are
an expression of a physical or mental illness or other conflicts and can be influenced by other
measures or treatment of the underlying disease.
Benzodiazepines do not eliminate the cause of the disorder. They reduce the burden of suffering and
can be an important aid, for example, to facilitate access to further treatments and to
solving the problem.
The use of benzodiazepines can lead to the development of physical and psychological dependence.
To minimize this risk, it is important to strictly adhere to the following instructions:

• 1. Benzodiazepines are only suitable for the treatment of pathological conditions and can only be taken according to the doctor's instructions.
• 2. If you currently or in the past have suffered from dependence on alcohol, drugs or narcotics, you should not take benzodiazepines, except in rare cases that can only be assessed by your doctor. Inform your doctor of this situation.
• 3. Prolonged and uncontrolled use should be avoided, as it can cause dependence. At the beginning of therapy, you should schedule a check-up visit with your doctor so that they can decide on further treatment. Taking these medicines without your doctor's instructions reduces the chances of being assisted by a prescription.
• 4. Never increase the dose prescribed by your doctor or reduce the time intervals between individual doses, even if the effect diminishes. This may be the first sign of an emerging dependence. Unauthorized changes to the dosage prescribed by your doctor make treatment more difficult.
• 5. Treatment with benzodiazepines should never be stopped abruptly, but only by gradually reducing the dose. If treatment is stopped after prolonged use, restlessness, anxiety, insomnia, convulsions and hallucinations may occur, often with a delay of a few days. These withdrawal symptoms disappear after a few days or weeks. Consult your doctor if necessary.
• 6. Never accept benzodiazepines from other people and do not take them just because "they have helped others so well". Never give these medicines to others.